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Merck's Keytruda Gets FDA Priority Review for Rare Lymphoma

Merck MRK announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) looking for label expansion of its marketed drug, Keytruda (pembrolizumab), for a rare lymphoma indication.

The sNDA is looking to expand Keytruda’s label for treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma (“NHL”). With the FDA granting a priority review, its response is expected on Apr 3, 2018. If finally approved, this would be the second nod for Keytruda from the regulatory body for treating a hematologic malignancy indication.

In March/April, Keytruda was approved both in the United States as well as the EU for refractory classical Hodgkin lymphoma, the first Keytruda approval for hematologic malignancy indication.

Merck’s shares have declined 3.3% this year so far, underperforming the industry’s16.4% rally.

The sBLA was accepted by the FDA based on encouraging data from the ongoing phase II KEYNOTE-170 and the phase Ib KEYNOTE-013 studies. Both trials are evaluating the safety, tolerability and efficacy of Keytruda as a monotherapy on patients with various blood cancers.

In the same press release, the company released outcomes from the KEYNOTE-170 study. Data from the study demonstrated that patients with a relapsed/refractory PMBCL achieved an overall response rate of 41%. Additionally, 24% of patients achieved a complete response rate and a 17% partial response rate at median follow-up of 10.5 months. The drug was however, unable to achieve the median duration of response. Finds from the study were presented at the 59th annual meeting of American Society of Hematology.

Notably, Keytruda was granted a Breakthrough Therapy Designation by the FDA in January for the aforementioned indication.

Per the company’s press release, PMBCL accounts for an almost 2-4% of all NHL in the United States. Hence, approval of the drug for this expanded indication will provide the company with access to a wider patient population with PMBCL.

We remind investors that Keytruda is the first anti-PD-1 therapy to gain an FDA approval and is being studied for more than 30 types of cancer in above 650 studies including 400 plus combination trials. Key recent approvals of drugs have been given for indications including advanced bladder cancer, advanced microsatellite instability-high cancers and the first approval as a combination therapy was granted with Eli Lilly's LLY cancer drugs Alimta (pemetrexed) and carboplatin (pem/carbo) for lung cancer.

Corcept’s earnings per share estimates have moved up from 77 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 137.5% year to date.

Achillion’s loss per share estimates has narrowed from 66 cents to 63 cents for 2017 and from 75 cents to 67 cents for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 4.51%.

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